Information
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Audit Title
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Document No.
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
4.1 General Requirements
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Has the organization established, documented, implemented and maintained a quality management system?<br>
4.2.1 Documentation Requirements - General
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Does the documentation include documented statements of a quality policy and quality objectives?<br>
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AS9100C - Has the organization ensured that personnel have access to, and are aware of, relevant quality management system documentation & changes?
4.2.2 Quality Manual
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Has the quality manual been established?<br>
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Is the quality manual maintained?<br>
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The scope of the quality management system including details of and justification for any exclusions (see 1.2)?
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a description of the interaction between the processes of the quality management system?<br>
4.2.3 Control of Documents
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Are all documents required by the quality management system controlled?<br>
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Has a documented procedure been established to define the controls needed to approve documents for adequacy prior to issue and subsequent up revision<br>
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to review and update as necessary and re-approve documents?<br>
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to ensure that changes and the current revision status of documents are identified?<br>
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to ensure that relevant versions of applicable documents are available at points of use?<br>
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to ensure that documents remain legible and readily identifiable?<br>
4.2.4 Control of Records
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Have records been established to provide evidence of conformity to requirements and of the effective operation of the quality management system?<br>
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Has a documented procedure been established to define the controls needed for the identification of records?
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Are they controlled?<br>
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Storage of records?<br>
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Protection of records?<br>
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Retrieval of records?<br>
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retention time of records? Minimum 10 years <br>
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Are records legible?<br>
5.1 Management Commitment
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Is there evidence of commitment by top management toward the development, implementation and improvement of the quality management system and continually improving its effectiveness by:
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a) communicating to the organization the importance of meeting customer’s, statutory and regulatory requirements?<br><br><br><br>
5.2 Customer Focus
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Does top management ensure that customer requirements are determined?<br>
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Does top management ensure that customer requirements are met?<br>
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Is this with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1)?<br>
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AS9100C - How does top management ensure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not, or will not be achieved?
5.3 Quality Policy
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How has top management ensured that the quality policy:
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c) provide a framework for establishing and reviewing quality objectives?
5.4 Planning
5.4.1 Quality Objectives
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How has top management ensured that quality objectives, including those needed to meet requirements for product (see 7.1a), are established at relevant functions & levels within the organization? Quality objectives shall be measurable and consistent with the quality policy.
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Are the quality objectives measurable?<br>
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Are the quality objectives consistent with the quality policy?<br>
5.4.2 Quality Management System Planning
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Does top management ensure that:<br>
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a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives?
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b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented?<br>
5.5.1 Responsibility and Authority
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Has the organisation an organisation chart which defines roles and responsibilities and authorisations<br>
5.5.2 Management Representative
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Has top management appointed a member of its management:
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AS9100C - d) the organizational freedom and unrestricted access to top management to resolve quality management issues?
5.5.3 Internal Communication
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How does top management ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness if the quality management system?
5.6.1 Management Review - General
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Does the top management review the organization’s quality management system, at planned intervals, to ensure its continuing stability, adequacy and effectiveness?
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Does this reviews include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy & objectives?
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Are records from management reviews maintained? (see 4.2.4)
5.6.2 Review Input
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Does management review inputs including:
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Results of audits?<br>
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Process performance and product conformity?<br>
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Status of preventive and corrective actions?<br>
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Follow-up actions from previous management reviews?<br>
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Changes which could effect the quality management system?<br>and
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Recommendations for improvement?<br>
5.6.3 Review Output
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Does the output from management reviews include decisions & actions related to:
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a) Improvements to the quality management system and its processes?<br>
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b) Improvements to product related to customer requirements?<br>
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c) TImesales and owners for actions<br>
6.1 Provision of Resources
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Has the organization determined and provided the resources needed:
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a) to implement and maintain the quality management system & continually improve its effectiveness?
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b) to enhance customer satisfaction by meeting customer requirements?
6.2.1 Human Resources - General
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How does the organization determine personnel performing work affecting conformity to product requirements are competent on the basis of appropriate education, training, skills and experience?
6.2.2 Competence, Awareness & Training
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How has the organization:<br>
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a) determined the necessary competency for personnel performing work affecting conformity to product requirements?
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b) where applicable, provided training or taken other actions to achieve the necessary competence?
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c) evaluated the effectiveness of the action(s) taken?
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e) maintained appropriate records of education, training, skills & experience (see 4.2.4)
6.3 Infrastructure
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How does the organization determine, provided and maintain the infrastructure needed to achieve conformity to product requirements? Infrastructure includes, as applicable:
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a) Buildings, workspace and associated utilities,
6.4 Work Environment
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Has the organization determined and managed the work environment needed to achieve conformity to product requirements?
7. Product Realization
7.1 Planning of Product Realization
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In planning product realization, has the organization determined the following, as appropriate:
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a) Quality objectives and requirements for the product?
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b) The need to establish processes and documents and provide resources specific to the product?
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c) verification, validation, monitoring, measurement, inspection and test activities specific to the product
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c) Producibility & inspectability,
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records are needed to provide <br>
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AS9100C - f) resources to support the use and maintenance of the product. Is the output of this planning in a form suitable for the organization’s method of operation?<br><br>
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d) Suitability of parts & materials used in the product,
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e) Selection & development of embedded software,
7.1.1 Project Management
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AS9100C - As appropriate to the organization and the product, does the organization plan and manage product realization in a structured and controlled manner to meet requirements at acceptable risk, within resource and schedule constraints?
7.1.2 Risk Management
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AS9100C - Has the organization established implemented and maintained a process for managing risk to the achievement of applicable requirements, that includes as appropriate to the organization and the product:
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AS9100C - a) assignment of responsibilities for risk management<br><br>
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AS9100C - b) definition of risk criteria (e.g., likelihood, consequences, risk acceptance)<br><br>
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AS9100C - c) identification, assessment and communication of risks throughout product realization<br><br>
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AS9100C - d) identification, implementation and management actions to mitigate risks that exceed the defined risk acceptance criteria, and<br><br>
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AS9100C - e) acceptance of risk remaining after implementation of mitigating action<br><br>
7.1.3 Configuration Management
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AS9100 C - Has the organization established, implemented & maintained a configuration management process that includes, as appropriate to the product:
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AS9100C - a) configuration management planning
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AS9100C - b) configuration identification<br><br>
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AS9100C - c) change control
7.1.4 Control of Work Transfers
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AS9100C - Has the organization established, implemented and maintained a process to plan and control the temporary or permanent transfer of work (e.g., from one organization facility to another, from the organization to a supplier, from one supplier to another supplier) and to verify the conformity of work to requirements?
7.2.3 Customer Communication
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Has the organization determined & implemented effective arrangements for communicating with customers in relation to:
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a) Product information?<br>
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b) Enquiries, contracts or order handling, including amendments? and<br>
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c) Customer feedback, including customer complaints?<br>
7.4.1 Purchasing Process
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AS9100C - Is the organization responsible for the conformity of all products purchased from suppliers, including product from sources defined by the customer?
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Is the criterion for selection, evaluation, & re-evaluation (of suppliers) established?
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AS9100C - a) maintain a register of its suppliers that includes approval status (e.g., approved, conditional, disapproved) and the scope of the approval (e.g., product type, process family),
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AS9100C - b) periodically review supplier performance; are results of these reviews used as a basis for establishing the level of controls to be implemented,
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AS9100C - c) define the necessary actions to take when dealing with suppliers that do not meet requirements,
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AS9100C - d) ensure when required that both the organization and all suppliers use customer-approved special process sources,
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AS9100C - e) define the process, responsibilities and authority for the approval status decision, changes of the approval status and conditions for a controlled use of suppliers depending on the supplier’s approval status, and
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AS9100C - f) determine and manage the risk when selecting and using suppliers? (see 7.1.2)
7.4.2 Purchasing Information
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Does purchasing information describe the product to be purchased, including where appropriate:<br><br>
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AS9100C - d) the identification and revision status of specification, drawings, process requirements, inspection/verification instructions and other relevant technical data,
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AS9100C - e) Where applicable requirements for design, test, inspection, verification (including production process verification), use of statistical techniques for product acceptance, and related instructions for acceptance by the organi-zation, and as applicable identification of critical items including key characteristics<br><br>
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AS9100C - f) requirements for test specimens (e.g., production methods, number, storage conditions) for design approval, inspection/ verification, investigation or auditing,<br>
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How. does the organization flow down the requirements to the supplier including customer specifics
7.4.3 Verification of Purchased Product
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Has the organization established a goods receiving and verification of products purchased<br>
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AS9100C - Where product is released for production has traceability been established
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AS9100C - When the organization delegates verification activities to the supplier, are the requirements for delegation defined and a register of delegation maintained?
7.5.1 Production
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How does the supply control production during realisation activities (example route cards)
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Does (the organization’s) controlled conditions include as applicable:
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a) The availability of information that describes the characteristics of the product?<br><br>> Note: This information can include drawings, parts lists, materials & process specifications
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b) the availability of work instructions, as necessary?<br><br>> AS9100C Note: Work instructions can include process flow charts, production documents (e.g., manufacturing plans, travelers, routers, work orders, process cards) and inspecttion documents.
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f) The implementation of product release, delivery and post-delivery activities?
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AS9100C - Traceability for all product during production (e.g., parts quantities, split orders, nonconforming product),<br>
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AS9100C - evidence that all production and inspection /verification operations have been completed as planned, or as otherwise documented and authorized,<br>
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AS9100C - provision for the prevention, detection and removal of foreign objects,<br>
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AS9100C - establishing, implementing and maintaining appropriate processes to manage critical items, including process controls where key characteristics have been identified,<br>
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AS9100C - Identifying in-process inspection/verification points when verification of conformance cannot be performed at later stages of manufacturing.<br>
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AS9100C - Special processes (see 7.5.2).
7.5.1.1 AS9100C - Production Process Verification
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AS9100C - Are FAI completed in accordance with AS9102 Rev A ?<br>
7.5.1.2 AS9100C - Control of Production Process Changes
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AS9100C - Are personnel authorized to approve changes to production processes identified?<br>
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AS9100C - Does the organization control & document changes affecting processes, production equipment, tools or software programs? <br>
7.5.1.3 AS9100C - Control of Production Equipment, Tools, & Software Programs
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AS9100C - How does the organization validate production equipment and software and control changes in software programme<br><br>
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AS9100C - How has the organization defined storage requirements, including periodic preservation / condition checks, for production equipment or tooling in storage?
7.5.1.4 AS9100C - Post Delivery Support
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AS9100C - Is post delivery support provided as applicable for:<br>
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AS9100C - notification to customer if non conformity detected which can effect customer<br>
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AS9100C - approval, control and use of repair schemes approved by customer prior to commencement of rework.<br>
7.5.2 Special process
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How does the organization validate any processes for production & service provision where the resulting output cannot be verified by subsequent monitoring or measurement &, as a consequence, any deficiencies made apparent only after the product is in use or the service has been delivered?
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Has the organization’s validation demonstrated the ability of these processes to achieve planned results?
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Has the organization established arrangement for these processes including, as applicable:,<br>
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a) defined criteria for review & approval of the processes to achieve planned results?
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b) approval of equipment and qualification of personnel?
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c) use of specific methods & procedures?
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d) requirements for records (see 4.2.4)?, and
7.5.3 Identification and traceability
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Has the organization identified, where appropriate, the product by suitable means throughout production realization?
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AS9100C - Does the organization maintain the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration?
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Does the organization identify product status with respect to its monitoring & measurement requirements throughout product realization?
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AS9100C - When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), has the organization established appropriate controls for the media?
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Does the organization control & record the unique identification of the product, where traceability is a requirement? (see 4.2.4)
7.5.4 Customer property
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How does the organization exercise care with customer property while it is under the organization’s control or being used by the organization?<br>
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Does the organization identify, verify, protect & safeguard customer property provided for use, report this to the customer & maintain records? (see 4.2.4)
7.5.5 Preservation of product
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What are the processes/ procedures established by the organization to preserve the conformity of the product during internal processing and delivery to the intended destination in order to maintain conformity to the requirements?
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Do these processes/procedures include:<br>
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Does preservation also apply to the constituent parts of a product also?
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Product handling?<br>
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Product storage?<br>
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Product protection?
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AS9100C - Does preservation of the product also include, where applicable iaw product specifications and applicable statutory & regulatory requirements, provisions for:<br>
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AS9100C - b) prevention, detection & removal of foreign objects?
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AS9100C - c) special handling for sensitive products?
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AS9100C - d) marking & labeling including safety warnings?<br>
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AS9100C - e) shelf life control & stock rotation?
7.6 Control of monitoring and measuring equipment
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AS9100C - Does the organization maintain a register of the monitoring & measuring equipment.
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AS9100C - Does the organization ensure that environmental conditions are suitable for the calibration, inspection, measurement & testing being carried out?
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calibrated or verified, or both, at specific intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded? (see 4.2.4)<br>
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identified in order to determine its calibration status?
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process for the recall of monitoring & measuring equipment requiring calibration or verification?
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Are records of the results of calibrations & validations maintained? (4.2.4)
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When used in the monitoring & measurement of specified requirement, does the organization have the ability of computer software to satisfy the intended application, & how is this confirmed? <br><br>> This shall be undertaken prior to initial use & reconfirmed as necessary.
8.1 Measurement, analysis and improvement - General
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Has the organization planned & implemented monitoring, measurement, analysis and improvement processes needed:<br>
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a) to demonstrate conformity to product requirements?<br>
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b) to ensure conformity of the quality management system? <br>
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c) to continually improve the effectiveness of the quality management system? <br>
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Does this include determine-ation of applicable methods, including statistical techniques, & the extent of their use?
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Process control:,
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Selection & inspection of key characteristics,<br><br>
8.2.1 Customer satisfaction
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As one of the measurements of the performance of the quality management system, does the organization monitor information relating to customer perception as to whether the organization has met customer requirements? <br><br><br>Are organizational methods to obtain & using this information determined?
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AS9100C - Does the information to be monitored & used for the evaluation of customer satisfaction include, but is not limited to, product conformity, on-time delivery performance, customer complaints and corrective action requests?
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AS9100C - Has the organization developed & implemented plans for customer satisfaction improvement that address deficiencies identified by these evaluations, & assessed the effectiveness of the results?
8.2.2 Internal Audit
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Does the organization conduct internal audits at planned intervals ?<br>
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Is effectively implemented & maintained
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AS9100C - Do planned arrangements include customer contractual requirements?<br>
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Is the audit program planned, taking into consideration the status & importance of the processes & areas to be audited, as well as the results of previous audits?
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Is the audit criteria, scope and frequency ?<br>
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Does the selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process?
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Does the organisation allocate the closures of non conformities to the responsible manager for timely closure <br><br>
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Is there evidence of follow-up activities include the verification of the actions taken (see 8.5.2)
8.2.3 Monitoring and measurement of processes
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Do these methods demonstrate the ability of the process to achieve planned results?
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When planned results are not achieved, are corrections and corrective actions taken.?
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a) taken appropriate action to correct the nonconforming process?<br>
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b) evaluated whether the process nonconformity has resulted in product nonconformity, <br>
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c) determined if the process nonconformity is limited to a specific case or whether is could have affected other processes or product, and<br>
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d) identified and controlled any nonconforming product?<br>
8.2.4 Monitoring and measurement of product
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Does the organization monitor & measure product characteristics to verify that product requirements have been met?
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Does the organization maintain evidence of conformity with the acceptance criteria?
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criteria for acceptance and/or rejection?<br>
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where in the sequence measurement & testing operations are to be performed?<br>
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required records of the measurements results including where applicable testing and verification
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AS9100C - When critical items, including key characteristics have been identified, does the organization ensure they are controlled & monitored.?
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AS9100C - When the organization uses sampling inspection as verification IS the plan to international standard (AQL)
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AS9100C - Where product is released for production use pending completion of all required measurement & monitoring activities, is the product identified & recorded to allow recall & replacement if it is subsequently found that the product does not meet requirements?
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List of personnel who can release the product for delivery to the customer? (see 4.2.4)
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AS9100C - Where required to demonstrate product qualification, has the organization ensured that records provide evidence that the products meets the defined requirements?
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Does the organization hold up product release until planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.)?
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AS9100C - Does the organization ensure that all documents required to accompany the product are present at delivery?
8.3 Control of nonconforming product
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Does the organization ensures that product which does not conform to product requirements is identified and controlled to prevented its unintended use or delivery?<br>
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AS9100C - Does the organization’s documented procedure define the responsibilities & authority for the review & disposition of nonconforming product, & the process for approving personnel making these decisions?
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Where applicable, does the organization deal w/ noncom-forming product by one or more of the following ways?:<br>
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a) by taking action to eliminate the detected nonconformity?<br>
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b) by authorized its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer?<br>
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d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started?
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AS9100C - Does the organization’s nonconforming product control process provide for timely reporting of delivered nonconforming product?
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AS9100C - Note: Parties requiring notification of nonconforming product can include suppliers, internal organizations, customers, distributors & regulatory authorities.
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AS9100C - e) by taking action necessary to contain the effect of the nonconformity on other processes or products?
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AS9100C - Does the organization have procedures in place to ensure that dispositions of USE AS IS or REPAIR shall only be used after approval by an authorized representative of the organization responsible for the design?
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AS9100C - Note: Authorized representative includes personnel having delegated authority from the design organization.<br>The organization shall not use dispositions of USE AS IS or REPAIR, unless specifically authorized by the customer, if the nonconformity results in a departure from the contract requirements.
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AS9100C - Is product dispositioned for SCRAP conspicuously & permanently marked, or positively controlled, until physically rendered unusable?
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When nonconforming product is corrected is it subject to re-verification to demonstrate conformity to the requirements?
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Does the organization have a process to maintain records of the nature of nonconformities & any subsequent actions taken, including concessions obtained? (see 4.2.4)
8.4 Analysis of data
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Has the organization deter-mined, collected & analyzed appropriate data to demon-strate the suitability and effectiveness of the quality management system & to evaluate where continual improvement of the effective-ness of the quality manage-ment system can be made?
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Does this include data generated as a result of monitoring & measurement & from other relevant sources?<br>
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Does organization’s analysis of data provide information relating to:
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a) customer satisfaction? (see 8.2.1)<br>
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b) conformity to product requirements? (see 8.2.4)<br>
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c) Characteristics & trends of process & products, including opportunities for preventive action? (see 8.2.3 & 8.2.4), and
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Does the organization continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data,?
8.5.1 Continual improvement
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Does the organization use the following information to facilitate continual improvement of the Quality Management System through the use of:<br>
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a) Quality policy?<br><br>
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b) Quality objectives?<br><br>
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c) Audit results?<br><br>
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d) Analysis of data?<br><br>
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e) Corrective & preventive action?<br><br>
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f) Management review?
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AS9100C - Does the organization monitor the implementtation of improvement activities & evaluate the effectiveness of the results?
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AS9100C - Note: Continual improvement opportunities can result from lessons learned, problem resolutions & the benchmarking of best practices.
8.5.2 Corrective action
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Has the organization taken action to eliminate the causes of nonconformities in order to prevent recurrence? <br>
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Are Corrective Actions appropriate to the effects of the nonconformities encountered? <br>
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Is a documented procedure established to defined requirements for:<br>
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a) Reviewing nonconformities (including customer complaints)?<br>
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b) Determining the cause of nonconformities?<br>
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c) Evaluating the need for actions to ensure that nonconformities do not recur?<br>
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d) Determining & implementing the corrective action needed?<br>
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e) Records of the results of action taken? (see 4.2.4)
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f) Reviewing the effectiveness of corrective action taken?
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AS9100C - g) flowing down corrective action requirements to a supplier when it is determined that the supplier is responsible for the, nonconformity,<br><br>
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AS9100C - h) specific action where timely and/or effective corrective actions are not achieved, and
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AS9100C - i) determining if additional nonconforming product exists based on the causes of the nonconformities & taking further action when required.
8.5.3 Preventive action
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Has the organization determined actions appropriate to eliminate the causes of potential nonconformities in order to prevent their occurrence?
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Are preventive action shall be appropriate to the effects of the potential problems?
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Has the organization estab-lished a documented procedure to define requirements for:<br>
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a) determining potential non-conformities & their causes?
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b) evaluating the need for actions to prevent occurrence of non-conformities?
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c) determining and implementing action needed?
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d) recording the results of actions taken? (see 4.2.4), and
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e) Reviewing the effectiveness of the preventive action taken?
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AS9100C - Note: Examples of preventive action opportunities include risk management, error proofing, failure mode and effect analysis (FMEA), & information on product problems reported by external sources.
